Tailored Anti-Inflammatory (A-I) Diet for Hispanics with Ulcerative Colitis (UC)

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis

• Registration Number: NCT06784323
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the Hispanics/Latino (H/L) diet on disease remission in H/L patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-20
• Status Verified: 2025-03
• Study Start: 2025-03-05
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2030-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Documented diagnosis with ulcerative colitis from medical records.
• Self-Identify as Hispanic /Latino
• Ages 16-75
• SCCAI between 3-9 (no greater than 12 bowel movements a day)
• Fecal calprotectin > 150mg/dl.
• On stable medications for their disease for the past 3 months
• Likeability of Latin foods (starchy vegetables, rice, tropical fruits, plantains)
• No recent Inflammatory Bowel Disease (IBD) related hospitalization in the last month.

Exclusion Criteria

• Diagnosis of Crohn's Disease (CD).
• Prior ileoanal anastomosis (J-pouch) or diversion
• No recent hospitalizations on the last 4 weeks
• No Clostridium difficile or enteric infections on the last 4 weeks
• No use of probiotics on the last 4 weeks
• Patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory diet
• No active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
• Pregnancy, breastfeeding or planning to become pregnant during study period
• Use of Total Parenteral Nutrition at the time of screening and during the study period
• Other significant or life-threatening co-morbidities
• The need for antibiotic use during the study period
• Adults unable to consent
• Ages less than 16 and > 75 years old
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Clinical remission after diet intervention measured by simple clinical colitis activity index (SCCAI)	Up to 8 weeks	Will be measured with SCCAI \<=2.0. Score of 2 or less indicates remission from ulcerative colitis (UC).
Fecal calprotectin	Up to 8 weeks	Will be measured \<150 μg/g

Trial Locations

Locations (1)

University of Miami Health System; 🇺🇸 Miami, Florida, United States